Posted Oct 24, 2018 5:03:33 PM
By Bob DeAngelis
The 6 Vital Criteria You Should Require
If your goal is to improve health outcomes through the application of specialized coatings that advance and enhance functionality and performance with your medical devices, guide wires, core wires, coils, needles, mandrels, and instruments, then it is imperative to find a fluoropolymer coating partner that has established rigorous processes to meet your high standards.
The coating applicator you partner with should already have systems in place that include methods, application technology, formulations, and process qualifications. Adherence to these will enable the supplier to provide uniform coverage and adhesion.
The 6 Vital Criteria
The 6 vital criteria you should require of a fluoropolymer coating partner are the following:
- Expertise in coating and handling medical device products
- Expertise in medical device cleaning methods and surface preparation
- Intense focus on deposition control
- Process control culture
- Adherence to ISO 13485
- Company culture—medical device mindset
The first five are common sense considerations, keeping in mind that all fluoropolymer coating applicators are not the same and their performance within any of the above criteria can vary greatly. The criteria are interdependent, so if one lacks integrity in process or execution, it can compromise some or all of the others.
Medical Mindset & Transparency
Let’s talk about the sixth criteria: a medical mindset.
Transparency provides insurance that all parties deliver as they should. Nowhere is it more vital than in medical device markets to adhere to a full transparency policy. Fluoropolymer coating projects call for collaboration between experienced teams highly focused on strategic problem solving. Full and open communication between supplier staff is essential. When looking for fluoropolymer coating on medical devices, find a supplier that has staff with medical device experience from CMOs and OEMs—a proven track record of success from within the business provides optimal assurance for getting the best advice. What will that look like? Fluoropolymer applicator staff should be well-versed in the critical aspects of the medical device industry. They can synchronize inspection criteria, methods, and equipment, and are able to provide a clear definition of design goals.
Careful, Controlled Environment
An environment that carefully manages and controls processes and changes keeps those clearly
defined goals consistently on track. Highly structured change-control processes must evaluate the consequences and controls necessary to make changes, as well as gauge their impact. Design and process FMEAs (failure mode effects analysis) must be in place, any unintended consequences monitored, and change controls managed by a point person who documents changes and data, anticipates and analyzes impacts of any changes, and reports all changes to and collects approvals from all parties involved. No critical process variables change without authority—no critical process or tooling is changed, not even personnel, without being vetted, documented, and approved. All of this information should be openly available to the customer.
How We Operate
At Precision Coating, we work from a medical device mindset and collaborate with full and open communication among all stakeholders. Transparency is key to our partnership with you, and a backbone value instilled in our culture. It drives our behaviors—and behaviors combined with capabilities deliver results.
We recognize that much responsibility for patient health outcomes rests on the performance of your products. These six items are critical for a fluoropolymer coating applicator to keep pace with the increasing demands of the medical device industry—allowing customers to do so, as well. Technical demands keep intensifying, and to survive in the industry requires having a medical device mindset. In the final analysis, the fluoropolymer applicator’s culture is probably the most important of all the other five criteria. For a more in-depth discussion about these criteria, download the eBook, “Selecting a Medical Device Fluoropolymer Coating Applicator” now.